Uyu munsi, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika buratanga incamake yamakuru aturuka hirya no hino muri iki kigo:

• Uyu munsi, FDA yagiriye inama abakiriya ibyago byo gufatwa nimpanuka, cyane cyane nabana ,.ibicuruzwa biribwa birimo THC.Kwinjira mu buryo butunguranye ibyo bicuruzwa biribwa bishobora gutera ibintu bibi bikomeye.
• Uyu munsi, FDAyatanzweubuyobozi bwa nyuma bwiswe “Kugabanya ingaruka ziterwa n’umutekano wa Microbial mu musaruro wimbuto zimera: Ubuyobozi bwinganda. ”Aya mabwiriza agaragaza impungenge zikomeye za FDA ku bijyanye n’indwara ziterwa n’ibiribwa ziterwa no kurya imimero mbisi kandi itetse byoroheje kandi igaha ibigo ingamba zifatika zo gukumira ubusambanyi mu mbuto zose z’imbuto zimera.
• Ku wa kane, FDAyemereye kwamamazay'ibicuruzwa bitandatu bishya by'itabi binyuze mu nzira ya Premarket Itabi ry'ibicuruzwa (PMTA).FDA yatanzekwamamaza byatanze amabwiriza (MGO)kuri RJ Reynolds Vapor Company kuri Vuse Vibe yayoigikoresho cya e-itabihamwe no guherekeza itabi rifite uburyohee-amazi, kimwe no ku gikoresho cyacyo cya Vuse Ciro e-itabi hamwe no guherekeza itabi rifunzee-amazipod.FDA kandi yatanze amabwiriza yo guhakana ibicuruzwa muri RJ Reynolds Vapor Company kubindi byinshi Vuse Vibe na Vuse Ciroe-itabi.Byongeye kandi, ibicuruzwa bifite uburyohe bwa menthol byatanzwe nisosiyete biracyasuzumwa na FDA.
• Ku wa kane, FDA yemeje Radicava ORS (edaravone) guhagarika umunwa kugirango ivure amyotrophique latal sclerose (ALS).Radicava ORS ni verisiyo yatanzwe mu magambo ya Radicava, yariubanza byemejwe muri 2017 nkumuvuduko wamaraso (IV)kuvura ALS, bakunze kwita indwara ya Lou Gehrig.Radicava ORS yiyobora kandi irashobora kujyanwa murugo.Nyuma yo kwiyiriza ijoro ryose, Radicava ORS igomba gufatwa mugitondo kumunwa cyangwa binyuze mumiyoboro igaburira.Imiti yo mu kanwa ifite gahunda yo kunywa kimwe na Radicava - uburyo bwo kuvura bwa mbere bwo kunywa buri munsi iminsi 14, bukurikirwa nigihe cyiminsi 14 itarimo ibiyobyabwenge ndetse nubuvuzi bwakurikiranye bugizwe no kunywa buri munsi mugihe 10 muminsi 14, n'iminsi 14 idafite ibiyobyabwenge.Ingaruka zikunze kugaragara kuri Radicava ni ugukomeretsa (contusions), ibibazo byo kugenda (guhungabana gait), no kubabara umutwe.Umunaniro ningaruka zishoboka zituruka kuri Radicava ORS.Radicava na Radicava ORS birashobora kugira ingaruka zikomeye zijyanye na allergique zirimo imitiba, guhubuka, no guhumeka neza.Ku barwayi bafite sulfite sensitivite, sodium bisulfite - ibigize Radicava na Radicava ORS - bishobora gutera ubwoko bwa allergique ishobora guhitana ubuzima.Uwitekakwandika amakuruikubiyemo amakuru yinyongera kubyerekeye ingaruka zijyanye na Radicava ORS.
• Ku wa kabiri ,.Ikigo cya FDAyo gusuzuma ibiyobyabwenge nubushakashatsi (CDER) yatangaje itangizwa rishyaKwihutisha Gahunda idasanzwe yo gukiza indwara (ARC).Icyerekezo cya Porogaramu ya ARC ya CDER kirihuta kandi cyongera iterambere ryuburyo bwiza bwo kuvura bukemura ibibazo by’abarwayi bafite indwara zidasanzwe.Nibikorwa bya CDER hamwe nubuyobozi buhagarariwe nibiro byinshi muri Centre.Mu mwaka wa mbere, Porogaramu ya ARC ya CDER izibanda ku gushimangira ubufatanye bw’imbere n’imbere n’abafatanyabikorwa kandi izahuza n’inzobere zo hanze kugira ngo zifashe kumenya igisubizo cy’ibibazo biterwa no guteza imbere imiti idasanzwe.CDER ifite icyizere cy'ejo hazaza h’iterambere ry’ibiyobyabwenge bidasanzwe kandi itegereje gukomeza uyu murimo w’ingenzi muri gahunda nshya ya CDER ARC - hamwe n’abarwayi, abarezi, amatsinda yunganira, abize, inganda, n’abandi bafatanyabikorwa - kugira ngo bakemure ubuvuzi bukomeye butavuwe ibikenewe by'abarwayi n'imiryango ibana n'indwara zidasanzwe.
• COVID-19 ivugurura ryibizamini:
  • Kuva uyu munsi, ibizamini 432 hamwe nicyitegererezo cyo gukusanya byemewe na FDA byemewe nimpushya zo gukoresha byihutirwa (EUAs).Muri byo harimo ibizamini bya molekile 297 hamwe n’ibikoresho byo gukusanya icyitegererezo, antibody 84 n’ibindi bizamini byo gukingira indwara, ibizamini 50 bya antigen, hamwe n’ikizamini cyo guhumeka 1.Hano hari uburenganzira 77 bwa molekuline hamwe na antibody 1 yemewe ishobora gukoreshwa nurugero rwakusanyirijwe murugo.Hariho EUA 1 yo kwipimisha mikorobe murugo, 2 EUAs yo kwandikirwa antigen murugo, 17 EUAs kuri antigen hejuru ya konte (OTC) murugo, na 3 kubizamini bya molekile OTC murugo.
  • FDA yemereye ibizamini 28 bya antigen hamwe na 7 ya molekulari ya porogaramu yo gusuzuma.FDA yemereye kandi 968 ubugororangingo uburenganzira bwa EUA.

Ibisobanuro bijyanye

FDA, ikigo kiri muri Minisiteri y’AmerikaUbuzimana Serivisi ishinzwe abantu, irengera ubuzima rusange yizeza umutekano, gukora neza, n’umutekano w’ibiyobyabwenge by’abantu n’amatungo, inkingo n’ibindi binyabuzima bikoreshwa mu bantu, n’ibikoresho by’ubuvuzi.Iki kigo kandi gifite inshingano z’umutekano n’umutekano by’igihugu cyacu gitanga ibiribwa, amavuta yo kwisiga, inyongeramusaruro, ibicuruzwa bitanga imirasire ya elegitoroniki, ndetse no kugenzura ibicuruzwa by’itabi.